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Optimization of VIM Targeting in Essential Tremor Surgery (Opti-VIM)

Primary Purpose

Essential Tremor

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Opti-VIM targeting in DBS surgery
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Essential Tremor focused on measuring Essential Tremor, Deep brain stimulation, Ventro-intermediate nucleus of the thalamus, Targeting, Asleep surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe essential tremor despite the optimal medical management
  • Age between 18 and 75 years
  • Normal MRI scan
  • Mattis Dementia Rating Scale (MDRS) score ≥ 130
  • Affiliation to the social security
  • Signed informed consent

Exclusion Criteria:

  • Depression (Beck Depression Inventory scale > 20)
  • Contra-indication to surgery or general anesthesia
  • Cerebral atrophy on MRI scan
  • Pregnant or breastfeeding women

Sites / Locations

  • CHU de Bordeaux
  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Severe essential tremor treated by DBS

Arm Description

Outcomes

Primary Outcome Measures

Change of Fahn-Tolosa-Marin (FTM) scale score
Scale global range : min=0 / max=160 Higher values represent worse tremor

Secondary Outcome Measures

Accelerometry recordings : spectral analysis
Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with spectral analysis.
Accelerometry recordings : calculation of the total accelerometry power
Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with calculation of the total accelerometry power.
Surgical complications
Onset of infection, hematoma or seizure
Device complications and dysfunction
rupture or displacement of electrode, pain at the stimulation box implantation site or along the subcutaneous cable if they require further intervention, infection.
Neurostimulation-related side effects
Onset of dysarthria and ataxia assessed by the items 1 to 4 of the Scale for Assessment and Rating of Ataxia (SARA), ataxia assessed by a posturometry analysis, paresthesia, muscular contractions
Quality of life: change of modified Parkinson's Disease Questionnaire-39 (mPDQ-39) scale score
Adaptation of Parkinson's Disease Questionnaire-39 to essential tremor Scale global range : min=0 / max=156 Higher values represent worse Quality of life
Coordinates of active contacts
Coordinates of active contacts (i.e; the contact with the best effect on tremor without side effects) These coordinates (x, y, z) are obtained by merging the images of the 3-month postoperative scanner with the images of the preoperative MRI.

Full Information

First Posted
November 26, 2018
Last Updated
May 10, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03760406
Brief Title
Optimization of VIM Targeting in Essential Tremor Surgery
Acronym
Opti-VIM
Official Title
Optimization of VIM Targeting in Essential Tremor Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.
Detailed Description
The intermedius ventralis nucleus of the thalamus (VIM), which represents the target for deep brain stimulation (DBS) in essential tremor, still remains invisible on 1,5 tesla MRI (the only magnetic field available for stereotactic surgery). The target coordinates currently used are based on stereotactic atlases or mean coordinates from retrospective series. They are so imprecise that intra-operative clinical testing and micro-electrode recordings are mandatory to locate the exact position of the VIM. This procedure is long lasting, requires that the patient is awake, and increases the risk of intracerebral haemorrhage and nosocomial infections. Furthermore, some patients are not improved despite a DBS lead implanted in the electrophysiologically and clinically defined target. To overcome these limitations, investigators developed a probabilistic model based on data extracted from imaging of patients with particularly good outcomes after DBS surgery. This machine-learning model allows calculating to coordinates of the VIM according to the position of radio-anatomical landmarks with a mean precision of 1,65mm. The aim of this study is to validate this new targeting method on a prospective cohort of patients. DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©). Neurostimulation device programming will be performed as usual. Patients' tremor and quality of life will be evaluated pre and post-operatively at 3 months, according to the Fahn-Tolosa-Marin (FTM) scale and with an accelerometry recording (for tremor) and with the mPDQ-39 scale for quality of life. Surgical complications and side effects related to neurostimulation will be gathered all along the follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential Tremor, Deep brain stimulation, Ventro-intermediate nucleus of the thalamus, Targeting, Asleep surgery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Severe essential tremor treated by DBS
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Opti-VIM targeting in DBS surgery
Intervention Description
DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©). The VIM coordinates will be calculated with the probabilistic model that have been developed.
Primary Outcome Measure Information:
Title
Change of Fahn-Tolosa-Marin (FTM) scale score
Description
Scale global range : min=0 / max=160 Higher values represent worse tremor
Time Frame
Before and 3 month after DBS surgery
Secondary Outcome Measure Information:
Title
Accelerometry recordings : spectral analysis
Description
Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with spectral analysis.
Time Frame
Before and 3 month after DBS surgery
Title
Accelerometry recordings : calculation of the total accelerometry power
Description
Accelerometry recordings at the pre-inclusion visit and at 3 months after surgery in ON and OFF-stimulation conditions with calculation of the total accelerometry power.
Time Frame
Before and 3 month after DBS surgery
Title
Surgical complications
Description
Onset of infection, hematoma or seizure
Time Frame
Up to 3 month after DBS surgery
Title
Device complications and dysfunction
Description
rupture or displacement of electrode, pain at the stimulation box implantation site or along the subcutaneous cable if they require further intervention, infection.
Time Frame
Up to 3 month after DBS surgery
Title
Neurostimulation-related side effects
Description
Onset of dysarthria and ataxia assessed by the items 1 to 4 of the Scale for Assessment and Rating of Ataxia (SARA), ataxia assessed by a posturometry analysis, paresthesia, muscular contractions
Time Frame
Up to 3 month after DBS surgery
Title
Quality of life: change of modified Parkinson's Disease Questionnaire-39 (mPDQ-39) scale score
Description
Adaptation of Parkinson's Disease Questionnaire-39 to essential tremor Scale global range : min=0 / max=156 Higher values represent worse Quality of life
Time Frame
Before and 3 month after DBS surgery
Title
Coordinates of active contacts
Description
Coordinates of active contacts (i.e; the contact with the best effect on tremor without side effects) These coordinates (x, y, z) are obtained by merging the images of the 3-month postoperative scanner with the images of the preoperative MRI.
Time Frame
3 month after DBS surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe essential tremor despite the optimal medical management Age between 18 and 75 years Normal MRI scan Mattis Dementia Rating Scale (MDRS) score ≥ 130 Affiliation to the social security Signed informed consent Exclusion Criteria: Depression (Beck Depression Inventory scale > 20) Contra-indication to surgery or general anesthesia Cerebral atrophy on MRI scan Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
USMR CHU de Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

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Optimization of VIM Targeting in Essential Tremor Surgery

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